Phase 2 Study of KHK4577 | NCT02004119

Studies
Phase 2 Study of KHK4577

NCT02004119

Sponsor

Kyowa Kirin Co., Ltd.

Status

Completed

Last Update Posted

Sep 11, 2018Actual

Enrollment

93Actual

Phase

Phase 2

Conditions

Atopic Dermatitis

Interventions

KHK4577
Placebo

Countries

Japan

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Aug 2018

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Nov 2013

Primary Completion Date

Dec 2014Actual

Completion Date

Dec 2014Actual

First Submitted Date

Dec 3, 2013

First Submission Date that Met QC Criteria

Dec 3, 2013

First Posted Date

Dec 6, 2013Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Sep 9, 2018

Last Update Posted Date

Sep 11, 2018Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

This study is an randomized double-blind placebo-controlled study to evaluate the efficacy and the safety of oral KHK4577 for 6 weeks in patients with atopic dermatitis. Pharmacokinetics of KHK4577 will also be assessed.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

93Actual

Label	Type	Description	Intervention Names
Placebo	Placebo Comparator		Drug: Placebo
KHK4577	Experimental		Drug: KHK4577

Name	Type	Description	Arm Group Labels	Other Names
KHK4577	Drug		KHK4577
Placebo

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Percent improvement from baseline in Eczema Area and Severity Index (EASI)		Pre-dose, Week 1,2,4 and 6

Secondary Outcomes

Measure	Description	Time Frame
Change from baseline in Investigator's Global Assessment score		Pre-dose, Week 1,2,4 and 6
Dermatology Life Quality Index		Pre-dose, Week 1,2,4 and 6
Visual Analog Scale (itching)

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Subject has signed voluntarily the written informed consent form to participate in this study.
Subject has been diagnosed as atopic dermatitis according to Guidelines for Management of Atopic Dermatitis (2009).
Rajka & Langeland criteria of >/= 4.5 at screening visit
Investigator's Global Assessment (IGA) score of >/= 3 at screening visit

Exclusion Criteria:

Evidence of skin disorders/conditions that would interfere with the assessment of the effect of the study drug.
Subject received photochemotherapy or systemic immunosuppressants within 2 weeks prior to informed consent.
Subject has any active infectious disease(except localized infection) which needs to treat with systemic antibiotics(eg. antibacterial, antifungal or antiviral drugs) within 4 weeks prior to informed consent.
Subject has complications / history of drug abuse or alcoholism.
Subject has drug allergy or history of allergic reaction to a drug medicine.
Subject has a significant concurrent medical conditions as defined in the study protocol.
Subject is breast-feeding, pregnant or planning to become pregnant in this study period.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

20 Years

Maximum Age

64 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
For additional information regarding investigative sites for this trial, contact Kyowa Hakko Kirin		Sapporo	Hokkaido	060-0063	Japan

Condition Browse Module

MeSH Terms

ID	Term
D003876	Dermatitis, Atopic

Ancestor Terms

ID	Term
D012873	Skin Diseases, Genetic
D030342	Genetic Diseases, Inborn
D009358	Congenital, Hereditary, and Neonatal Diseases and Abnormalities
D003872	Dermatitis

Browse Leaves

Not provided

Browse Branches

Not provided